BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 19229237 · Received May 2, 2024

    Report

    Report Number
    3005180920-2024-00277
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-APR-2024. LOT 093009: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-03-2020. EXPIRATION DATE: 2015-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 11 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS WITH COMPETITOR COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858326 AMISTEM H HA COATED STD STEM SIZE 1 HIP STEM LZO MEDACTA INTERNATIONAL SA 093009 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention